Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients

Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04587856

Enrollment

Registered

2020-10-14

Start date

2021-02-12

Completion date

2025-03-31

Last updated

2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Brief summary

This is a biological study for adult MDS patients who undergo HSCT procedure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant to study genomic and transcriptomic changes.

Detailed description

This is a biological study for adult MDS patients who undergo HSCT procedure.The research is focused on the study of biological mechanisms of disease relapse after HSCT in MDS to provide the rationale to develop pre-emptive strategies in patients with high risk of transplant failure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant by using Single-cell sequencing. To study genomic and transcriptomic changes in CD34+ blast cells at disease relapse after HSCT will be used TARGET-seq in parallel with unbiased whole-transcriptome analysis.

Interventions

OTHERbone marrow withdrawal

bone marrow samples evaluation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of MDS according to 2016 WHO criteria * Aged 18y or older * Patients who will receive allogeneic stem cell transplantation (HSCT) * Signed written informed consent according to ICH/EU/GCP and national local laws

Exclusion criteria

* Second HSCT procedure.

Design outcomes

Primary

Measure	Time frame	Description
CD34+ blast cells modifications	at 24 months	Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse.

Countries

Italy

Contacts

Primary ContactPaola Fazi

p.fazi@gimema.it0670390528

Backup ContactEnrico Crea

e.crea@gimema.it0670390514

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026